TPLC - Total Product Life Cycle

show TPLC since

Device	system, digital image communications, radiological
Definition	A medical image communications device provides electronic transfer of medical image data between medical devices. It may include a physical communications medium, modems, interfaces, and a communications protocol. It may provide simple image review software functionality for medical image processing and manipulation, such as grayscale window and level, zoom and pan, user delineated geometric measurements, compression, or user added image annotations. The device does not perform advanced image processing or complex quantitative functions.
Product Code	LMD
Regulation Number	892.2020
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
No Display/Image	3	3
Device Operational Issue	3	3
Complete Loss of Power	3	3
Unexpected Shutdown	2	2
Adverse Event Without Identified Device or Use Problem	2	2
Erratic or Intermittent Display	2	2
No Apparent Adverse Event	2	2
Fire	2	2
Smoking	1	1
Contamination /Decontamination Problem	1	1
Temperature Problem	1	1
Program or Algorithm Execution Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	13	13
Radiation Exposure, Unintended	3	3
Insufficient Information	1	1
Unspecified Infection	1	1
Bowel Perforation	1	1
Partial thickness (Second Degree) Burn	1	1